Purpose
The following product summary can be used by product providers to prepare orders for fall and winter virus season.
Presentations and Indications
mRESVIA is indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older.
Ordering and Return Policy
Minimum Initial Order
When ordering vaccines directly from Moderna, there is a minimum order of 10 doses.
Pre-ordering or Reservation Programs
Pre-ordering or reservation programs are offered for mRESVIA.
Return Policy
Unopened Vaccine
Unused vaccine that meets the requirements of Moderna's Return Goods Policy can be returned.
Customers can call 1-866-MODERNA (1-866-663-3762) for information on reservations and ordering.
Opened Vaccine
Unused Moderna pre-filled syringes are returnable that meet the requirements of Moderna's Return Goods Policy.
Storage Requirements
- Must be stored frozen (between -40⁰C and -15⁰C)
- Must be stored refrigerated (between 2⁰C and 8⁰C)
Storage and Handling
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Frozen Storage
Store frozen between -40°C to -15°C (-40°F to 5°F).
Storage after Thawing
Store at 2°C to 8°C (36°F to 46°F):
- Pre-filled plastic syringes may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to use. Storage at 8°C to 25°C (46°F to 77°F):
- Pre-filled plastic syringes may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours after removal from refrigerated conditions. Discard the pre-filled syringe if not used within this time. Syringes should not be returned to the refrigerator after being thawed at room temperature.
- Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.
- Do not refreeze once thawed. Do not shake.
Doses
| mRESVIA | |
|---|---|
| How the vaccine is supplied | Manufacturer-filled syringes |
| Number of doses per vial | N/A |
| Dosage | Administer a single dose (0.5 mL)
mRESVIA is supplied as follows: NDC 80777-345-90 Carton of 1 single-dose pre-filled plastic syringe in a blister pack containing 1 dose of 0.5 mL (NDC 80777-345-01). NDC 80777-345-96 Carton of 10 single-dose pre-filled plastic syringes, each syringe containing 1 dose of 0.5 mL (NDC 80777-345-01). Each carton contains 5 blisters, and each blister contains two syringes. Use one syringe per person per dose.
|
| Dose volume | 0.5 mL |
| Reconstitution | No |
Shelf Life
| Shelf Life | mRESVIA |
|---|---|
| Unopened, frozen vaccine | 18 months until the expiration date printed on the vials and cartons. |
| Unopened, refrigerated vaccine | 30 days |
| Opened, refrigerated vaccine | N/A - Supplied as Pre-Filled Syringe |
| Opened, room temperature vaccine | N/A - Supplied as Pre-Filled Syringe |